At FDA Public Meeting on LDT Regulation, Dx Firms, Labs Suggest Areas for Agency Attention | GenomeWeb

By Turna Ray

As it takes steps to lift its three-decade long practice of "enforcement discretion" over laboratory-developed tests, the US Food and Drug Administration shouldn't place overly burdensome requirements on laboratories that are not used to navigating the agency's regulatory landscape, representatives from the lab testing industry told the agency at a meeting last week.

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